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A Phase II/III Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer. PURPOSE: This randomized phase II/III trial is studying how well brain irradiation works and compares three different brain irradiation regimens in preventing brain metastases in patients with limited-stage small cell lung cancer.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
0 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed small cell lung cancer by fine needle
aspiration, biopsy, or 2 positive sputa

- Limited stage (I-IIIB)

- Confined to 1 hemithorax

- No T4 or N3 disease

- Complete response after induction chemotherapy (with or without thoracic
radiotherapy)

- Consolidative chest radiotherapy may be initiated before study

- No radiographic evidence of any of the following:

- Brain metastases

- Normal brain CT scan or MRI less than 1 month before study

- Ipsilateral lung metastases

- Malignant pleural effusion

- Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 75,000/mm^3

- Hemoglobin at least 10.0 g/dL^

Hepatic

- Not specified

Renal

- Not specified

Pulmonary

- See Disease Characteristics

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Neurological function class 1 or 2

- No epilepsy requiring permanent oral medication

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No other serious medical or psychiatric condition that would preclude study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- At least 1 week since prior chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- No prior external beam radiotherapy to the head or neck, including stereotactic
radiotherapy

- Concurrent thoracic radiotherapy allowed

Surgery

- Not specified

Other

- No concurrent antitumor agents

Gender: Both
Steward Physician(s)
  • Aaron H. Wolfson, MD
Facilities
  • Saint Anne's Hospital - Completed
Trial Interventions
Radiation
  • Prophylactic Cranial Irradiation (PCI)
Physician Researcher

Investigator Name:

  • Aaron H. Wolfson, MD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 2/Phase 3
Trial ID: NCT00057746
Volunteers:  Not Accepting Healthy Volunteers

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